As a food manufacturer, you must ensure safe food for consumers to protect them from food contamination and foodborne diseases. If this sounds daunting, remember that the FDA assists you with that mission by establishing the regulations for the food and beverage industry.
You know that if your products are FDA-approved, you have more possibilities and trust in the market. But what is the FDA? What is the role of the FDA in the food industry?
In this article, food manufacturers, processors, and distributors will learn everything about the Food and Drug Administration to improve food quality and food safety and secure a stable position in the food supply chain.
What is the FDA?
The FDA stands for the Food and Drug Administration. It is a U.S. government agency that is pivotal in safeguarding public health and protecting the national food supply chain. The agency also regulates pharmaceuticals, medical devices, cosmetics, tobacco products, and products that emit radiation.
The Food and Drug Administration was established in 1906 and is within the Department of Health and Human Services. The FDA ensures that the products it regulates are safe, effective, and properly labeled.
The agency strives to promote public health by providing evidence-based information about foods and medical products to maintain and protect public health.
The FDA protects the food supply and develops medical products to respond promptly to health threats.
As for the food and beverage industry, the FDA regulates food labeling and food additives. It standardizes manufacturing practices and conducts inspections of food processing facilities for health and safety regulatory compliance. The agency also implements food safety laws to protect people from foodborne diseases.
The FDA’s mission is to protect and promote public health and safety.
How Does the FDA Regulate Food Safety?
The agency implements a comprehensive strategy for monitoring food manufacturers, processors, distributors, consumers, etc. Let’s cover it in more detail and take a look at the FDA’s food safety programs and regulatory frameworks.
FSMA
The FSMA (Food Safety Modernization Act) law gives the FDA the power to control the cultivation, harvesting, and processing of food. The FSMA aims to promote and prioritize food safety and implement a preventive approach instead of responding to hazards in the supply chain.
FSMA rules, like FSMA rule 204, make the law more efficient, and following them helps food manufacturers better address food safety issues.
Guidance Documents and Regulatory Information
The FDA provides guidance documents and regulatory information to present the FDA’s take on a topic. The regulations aren’t strict; they mostly demonstrate what is better to be done. Food manufacturers can alternate their approach as long as they meet legal requirements.
GMP/cGMP
Current Good Manufacturing Practices describe the methods, equipment, facilities, and controls for producing processed food. By following cGMPs, you ensure the quality of food and dietary supplements. Moreover, cGMPs foster proper food packaging and labeling based on master manufacturing records.
HACCP
HACCP stands for Hazard Analysis and Critical Control Points. The HACCP system addresses food safety by analyzing physical, biological, and chemical hazards. HACCP can be implemented in raw material production, procurement, handling, manufacturing, distribution, and consumption.
FDA Food Code
The FDA’s Food Code, written and published by the FDA, provides the technical and legal basis for regulating the food and beverage industry’s retail and food service segments. The FDA Food Code helps food control jurisdictions at all governmental levels.
The first FDA Food Code was published in 1993. Up until 2001, it was issued every two years. Later, the FDA decided to publish the Codes every four years and provide a Food Code Supplement that updated or modified some points in the code. The following complete edition was published in 2005. Later, in 2007, the FDA published the Supplement to the 2005 Food Code. The most recent version of the Food Code was published in 2022.
The guidelines in the Food Code help food businesses create or improve food safety rules to ensure safe food preparation and consumer safety.
The Food Code provides food production and labeling guidelines and presents the requirements for cleaning, sanitation, and equipment to maintain food safety.
The FDA shares the following statistics about the number of states that adopted the Food Code as the basis for their own food safety regulations:
-
- Fifty states, including the District of Columbia, have adopted some version of the Food Code, with California as the only exception;
-
- Thirty-four states have adopted one of the three most recent versions (published in the last ten years);
-
- Eighteen states have adopted one of the two most recent versions (published during the previous five years);
-
- Two states have adopted the most recent version (published on December 28, 2022).
FDA Food Recalls
FDA recall means removing a food product that violates U.S. FDA regulations. Food can be recalled because of any foodborne pathogens found in it, such as salmonella. Physical hazards like glass, plastic, hair, etc., can also lead to a food recall, as can chemical food hazards. Parasites in food are another threat to human health and well-being, so if they are found in a product, they will be recalled as well.
FDA Food Recalls are complex, that’s why manufacturers must complete some tasks to mitigate the recall risks:
- Monitor FDA news and regulations
- Maintain quality records
- Create and implement a recall plan
- Regularly audit and inspect the facility and the processes
- Verify your suppliers with the Supplier Verification Program.
Simply speaking, if any threat to public health is identified, especially to the well-being of pregnant women, people with compromised immune systems, seniors, and children, a food recall will be an indispensable measure. That’s why sticking to food safety practices is vital to avoid foodborne illnesses and recalls.
What is Risk Assessment?
A food safety risk assessment is another way for the FDA to ensure public health and safety and secure the food supply chain.
How does it work?
The FDA scientists gather information about contaminants such as bacteria or viruses, under what conditions they survive and grow, how the food where the contaminant can be is transported, shipped, processed, stored, or grown, and how to prevent the contamination of that food.
After that, scientists estimate how much contamination or illness from a contaminant could be prevented if particular actions were taken at some stages of the food supply chain.
Risk assessments help identify contamination risks in the supply chain so manufacturers can prevent issues rather than deal with them later.
FDA Labeling Regulations
Proper labeling is essential for consumer safety, and food manufacturers must be well-informed of the labeling guidelines before offering their products to US consumers.
Most prepared foods, such as bread, canned or frozen food, snacks, drinks, etc., must be labeled. Nutrition labeling is optional for fruits and vegetables.
The FDA assures that foods produced in the US and imported into the country meet food safety standards and are labeled appropriately. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the fundamental federal laws that govern food products under the FDA’s jurisdiction.
The FDA provides a comprehensive food labeling guide, but let’s briefly cover some of the statements here:
-
- You must put all the necessary label statements or certain specified label statements on a PDP (Principal Display Panel), as well as other information on the information panel on the right of the PDP that is visible to a customer. The label statements that appear on the PDP and alternate PDP are the statement of identity, or the name of the food, and the net quantity statement, which indicates the amount of product.
-
- The information panel, located to the right of the PDP, must include information such as the address of the manufacturer, packer, or distributor, ingredients, nutritional information, and allergen information.
-
- The labels must be easy to read and straightforward so the consumer can easily understand the essential information.
-
- The ingredient list must be in descending order from the ingredient that weighs the most to the least.
-
- Declare any allergens in the food, even in trace amounts.
These are just some of the food labeling guidelines. They are extensive, and we cannot cover them in the blog. Nevertheless, the FDA labeling guide is easily accessible for food manufacturers.
The FDA’s Inspection and Compliance Mechanisms
The FDA implements a comprehensive approach to ensuring product safety, including inspections, investigations, laboratory testing, and more. Let’s explore the FDA inspections more and see their peculiarities and types.
FDA inspections are official onsite examinations of a facility to verify its compliance with federal law. These inspections are careful and critical and can be comprehensive reviews of the entire facility or focused on particular issues, such as recall or corrective actions.
The FDA takes a risk-based approach to identifying the facilities to inspect, which can be both foreign and domestic. The FDA oversees the world supply chain, so wherever a product is manufactured, Americans are sure it is safe for them.
The FDA inspects the FDA-regulated manufacturers, and if we consider the food manufacturing context, these will include:
-
- food processing facilities
-
- dairy and produce farms
-
- animal feed processors
-
- farms
-
- foreign food facilities and farms
Types of FDA Inspections
Surveillance inspection assesses a facility’s or farm’s regulatory compliance. It can also be based on some emerging trends. FDA surveillance inspections can be targeted and routine.
Targeted (or directed) inspections are conducted if particular food safety risks exist that could lead to contamination or have any other negative impact.
Routine inspections are conducted to check facilities and farms for compliance with regulations. The FDA FSMA (Food Safety Modernization Act) established the mandatory frequency of inspections at least once every three years for domestic high-risk facilities and at least once every five years for non-high-risk facilities.
Compliance Follow-Up inspections are needed to verify if the facility has fixed mistakes identified during the initial inspection. In other words, the FDA checks if the facility implemented corrective actions and now complies with the rules, ensuring public safety.
For-cause inspections are compliance follow-ups that verify whether a facility reacted to a particular issue, such as a recall, outbreak, customer complaint, etc. They are often expedited.
FDA Inspection Process
Here’s the general overview of the FDA inspection process:
- The inspectors arrive at a site, introduce themselves, demonstrate their credentials, and issue a Notice of Inspection (FDA Form 482, for domestic inspections only) to a person in charge (owner, operator, etc).
- After that, the investigators will start a system-based inspection with an interview to get or verify the information, such as the legal name of the business, its size, and the number of employees. If the FDA had previously inspected the facility and corrective actions were warranted, they would have asked about the corrective actions taken and verified if they had been implemented. The inspectors will choose the products to cover and gather operational information about operation hours, sanitation schedules, etc.
- Then, the investigators will walk through the facility (from the receipt of ingredients to product distribution) and observe the processes and procedures, manufacturing, and employee practices to see if they adhere to the FDA Good Manufacturing Practices (GMPs). At the same time, they will also review written procedures and records and talk to the employees to determine how processes and procedures are implemented.
- After the walk-through, the inspectors will request and review additional records to check specific operation aspects and areas. The investigators will also review and assess the processes and documents to see if they comply with the standards.
- After the review, inspectors list significant observations (FDA-483 Inspection Observations and FDA-4056 Produce Farm Inspection Observations). They can also discuss labeling deviations and other lesser observations made during the walk-through. This stage also allows management to ask questions and discuss important things, such as corrective actions.
- Within 15 working days after the inspection, the facility/farm must submit a written response to the FDA addressing corrective actions. The FDA highly recommends that there be written responses to written observations described in the FDA-483 or FDA 4056 and verbal observations discussed at the close-out meeting.
- When the inspection is over, the FDA assesses the compliance and considers further actions if needed and warranted. The agency will send a copy of the report to the person in charge with whom the inspectors met at the beginning of the audit (owner, operator, etc).
FDA’s Recent Developments and Future Directions
The FDA always takes advantage of every opportunity to improve its approach to guaranteeing public health. Here are some examples of how the agency encourages food safety culture, making food safety practices more profound and automated.
Digitized Food Safety and Traceability
The FDA introduced the New Era of Smarter Food Safety Blueprint, reflecting modernized food safety approaches. It strives to develop a safer, digitized, and traceable food system.
The FDA’s initiative is centered around the core elements, including tech-enabled traceability, more intelligent tools and approaches for prevention and outbreak response, modernizing business models and retail, and fostering a food safety culture.
FDA Traceability Rule
The FDA has implemented an innovative FSMA 204 rule known as the Food Traceability Rule. The rule demands more detailed record-keeping to make it easier to identify and locate potential contaminants and avoid foodborne disease outbreaks. It will enhance traceability to help respond efficiently to food safety hazards in the supply chain.
The compliance date for the FSMA 204 rule is January 20, 2026, so it’s high time you take care of recordkeeping procedures at your facility!
Achieve FDA Compliance with a Digital Solution
Complying with FDA regulations requires a comprehensive approach, which can be challenging. That’s why many food and beverage companies seek FDA compliance software solutions to facilitate the process and centralize their entire operations so they do not miss any important aspect required for FDA compliance.
At FoodReady, we offer various services and features, such as FDA consultants, Food Recall Consultants, FSMA 204 Consultants, and cloud-based food safety software, including a HACCP builder, traceability, recall management, document management features, and more.
FoodReady food safety and quality management software will help you reduce recall risks, prepare for FDA inspections and comply with the agency’s regulations, digitize food safety compliance, and increase the productivity and profitability of your food and beverage business.
Conclusion
The FDA ensures public health by controlling the national food supply chain. The agency regulates food safety through standards and practices like GMPs, FSMA, HACCP, etc. Its comprehensive approach to inspecting food facilities and farms also helps ensure that products produced domestically and abroad are safe for Americans.
The FDA regulations allow food manufacturers to adhere to food safety standards and produce safe and quality food, guaranteeing customer health and satisfaction and its development, financial growth, and stability.
If you feel overwhelmed about complying with the U.S. FDA standards, don’t hesitate to ask for help from a professional service like FoodReady that will guide you through the process and never let you make an uninformed decision or undesirable mistake that could lead to a recall.
